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Preparation method of clindamycin phosphate powder for injection

A technology for clindamycin phosphate and injection, which is applied in the field of medicine, can solve the problems of accelerating the decomposition of clindamycin phosphate, increasing production equipment requirements, and high production costs, so as to avoid decomposition and damage, increase unit output, and improve Yield effect

Inactive Publication Date: 2010-09-15
HUBEI HOPE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] 3. The preparation adopts solvent crystallization technology to reduce impurities, but this method solvent crystallization technology uses a large amount of ethanol (every 1kg of clindamycin phosphate is put into production, at least 100L of ethanol is required), and the loss of raw materials in the crystallization process is large, and the production cost higher
Because high temperature heating must be maintained for a long time in the production process, the requirements for production equipment are increased, and at the same time, high temperature accelerates the decomposition of clindamycin phosphate, increasing impurities

Method used

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  • Preparation method of clindamycin phosphate powder for injection
  • Preparation method of clindamycin phosphate powder for injection

Examples

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Embodiment 1

[0040] A preparation method of clindamycin phosphate for injection, comprising the following steps:

[0041] 1. Preparation of Clindamycin Phosphate Sterile Solution:

[0042] Take 500g of clindamycin phosphate, add 1000mL of 1M sodium hydroxide solution and stir to dissolve (the pH value of the solution is about 6.8 at this time), add activated carbon for decolorization for 30min, coarse filter to remove carbon, and then use a 0.22μm microporous membrane Filter until clear.

[0043] 2. Preparation of Clindamycin Phosphate Sterile Powder:

[0044] In the sterile environment of the production control area, add the sterile solution of clindamycin phosphate in step 1 to 1000ml of 1M hydrochloric acid ethanol solution after sterile filtration and adjust the pH to 4, then add 8000mL of sterile filtered ethanol And continue to stir for crystallization (equivalent to clindamycin phosphate: sodium hydroxide: water: ethanol ratio of 1: 0.08: 2: 16), filter, wash, and drain. Dry unde...

Embodiment 2

[0048] A preparation method of clindamycin phosphate for injection, comprising the following steps:

[0049] 1. Preparation of Clindamycin Phosphate Sterile Solution:

[0050] Take 500g of clindamycin phosphate, add 1500mL of 0.5M sodium hydroxide solution and stir to dissolve (the pH value of the solution is about 6.0 at this time), add activated carbon for decolorization for 30min, coarsely filter to remove carbon, and then use a 0.22μm microporous filter Membrane filtration until clear.

[0051] 2. Preparation of Clindamycin Phosphate Sterile Powder:

[0052] Under the sterile environment of the production control area, add the above-mentioned sterile solution of clindamycin phosphate to 750ml of 1M nitric acid ethanol solution after aseptic filtration to adjust the pH to 4, then add 15000mL of ethanol through aseptic filtration and Stir continuously to crystallize (equivalent to clindamycin phosphate: sodium hydroxide: water: ethanol at 1:0.06:3:30), filter, wash, and dr...

Embodiment 3

[0056] A preparation method of clindamycin phosphate for injection, comprising the following steps:

[0057] 1. Preparation of Clindamycin Phosphate Sterile Solution:

[0058] Take 500g of clindamycin phosphate, add 750mL of 2M sodium hydroxide solution and stir to dissolve (the pH value of the solution is about 8 at this time), add activated carbon for decolorization for 30min, coarse filter to remove carbon, and then use a 0.22μm microporous membrane Filter until clear.

[0059] 2. Preparation of Clindamycin Phosphate Sterile Powder:

[0060] Under the sterile environment of the production control area, add the above-mentioned aseptic clindamycin phosphate solution to 750ml of 1M sulfuric acid ethanol solution after aseptic filtration to adjust the pH to 4, then add 1500mL of ethanol through aseptic filtration and Stir continuously to crystallize (equivalent to clindamycin phosphate: sodium hydroxide: water: ethanol ratio of 1: 0.12: 1.5: 3), filter, wash, and drain. Dry ...

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Abstract

The invention discloses a preparation method of clindamycin phosphate powder for injection, comprising the following steps of: taking clindamycin phosphate, adding alkaline solution at room temperature, stirring for dissolving the clindamycin phosphate to prepare sterile solution having a high concentration; in the sterile environment, adding inorganic acid or organic acid to adjust the pH value of the solution, adding inert organic solvent to crystallize, depressurizing, filtering and drying to obtain sterile powder of clindamycin phosphate; under the sterile condition, packing the powder in a sterile vial, covering the vial with a butyl latex plug, rolling a aluminum cover so as to make sterile powder. Compared with a prior art, the invention has the advantages of low cost, simple production device, short production cycle and the like; and dissolution of samples at a high temperature is unnecessary in the production process, which prevents the clindamycin phosphate from being dissolved or damaged in the production process, so that the final product has the advantages of high purity (low impurity), little toxicity and side effects and stable quality. The invention is particularly suitable for large-scale production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and more specifically relates to a method for preparing clindamycin phosphate for injection by solvent crystallization. The product is suitable for clinically treating various infectious diseases caused by Gram-positive bacteria and anaerobic bacteria. Background technique [0002] Clindamycin Phosphate (Clindamycin Phosphate) is a chemically synthesized clindamycin derivative, and its chemical name is 6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamide) -1-Thio-7(S)-chloro-6,7,8-trideoxy-L-threo-α-D-galactopyranoside-2-phosphate. Its chemical structural formula is as follows ("Complete Works of Contemporary Structural Drugs"): [0003] [0004] This product has no antibacterial activity in vitro. It enters the body and is rapidly hydrolyzed into clindamycin. By acting on the 50S subunit of the ribosome of sensitive bacteria, it prevents the extension of the peptide chain, thereby inhibiti...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K31/7056A61P31/04
Inventor 刘万忠刘伟华
Owner HUBEI HOPE PHARMA
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